memantine for the treatment of social deficits in youth with disorders of impaired social interactions

Conditions: Autism; Autism Spectrum Disorder; Nonverbal Learning Disability

Summary: this study is a 12-week randomized-controlled trial of memantine hydrochloride (namenda) for the treatment of social impairment in youth with non-verbal learning disorder, high-functioning autism spectrum disorder, and related conditions. eligible participants will be males and females ages 8-18. this study consists of up to 6 visits to massachusetts general hospital.


Eligibility criteria:
inclusion criteria: * male \& female subjects ages 8-18 years (inclusive). * diagnostic statistical manual (dsm)-5 autism spectrum disorder (asd) diagnostic criteria as established by clinical diagnostic interview * at least moderate severity of social impairment as measured by a total raw score of ≥85 on the parent/guardian-completed social responsiveness scale-second edition (srs-2)14 and a score of ≥4 on the clinician-administered clinical global impression-severity scale (cgi-s)17. exclusion criteria: * iq ≤70 based on the wechsler abbreviated scale of intelligence-ii (wasi-ii) vocabulary and matrix reasoning subtests * impaired communicative speech * subjects currently treated with the following medications (known to impact glutamate levels): lamotrigine, amantadine, n-acetylcysteine, d-cycloserine * subjects treated with a psychotropic medication not listed above on a dose that has not been stable for at least 4 weeks prior to study baseline. * co-administration of drugs that compete with memantine for renal elimination using the same renal cationic system, including hydrochlorothiazide, triamterene, metformin, cimetidine, ranitidine, quinidine, and nicotine * initiation of a new psychosocial intervention within 30 days prior to randomization. * subjects who are pregnant and/or nursing. * subjects with a history of non-febrile seizures without a clear and resolved etiology. * subjects with a history of or a current liver or kidney disease. * clinically unstable psychiatric conditions or judged to be at serious suicidal risk. * subjects who meet on the kiddie schedule for affective disorders and schizophrenia (k-sads-e) for alcohol or drug dependence or abuse. if the subject has a recent history of substance abuse, there will be a two-week washout period before initiating the trial as an added precaution. there are no known safety issues relating to memantine and recent history of substance abuse. * serious, stable or unstable systemic illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease. * subjects with severe hepatic impairment (lfts \> 3 times uln). * subjects with genitourinary conditions that raise urine ph (e.g., renal tubular acidosis, severe infection of the urinary tract). * known hypersensitivity to memantine. * severe allergies or multiple adverse drug reactions. * a history of intolerance or adequate exposure to memantine, as determined by the clinician. * investigator and his/her immediate family defined as the investigator's spouse, parent, child, grandparent, or grandchild.

Keywords: autism massachusetts general hospital